Senior Medical Writer - Oncology Trials (Remote, ET Hours)

Hlx Life Sciences; United States; Remote; USD 90,000 - 150,000; Full time

Job summary

Hlx Life Sciences is seeking a Senior/Medical Writer with oncology clinical trials experience to join our expanding medical writing team. You will develop, review, and edit clinical and regulatory documents to support Phase I–III oncology programs and regulatory submissions.

The role requires strong scientific communication, the ability to translate complex data into clear content, mentorship of junior writers, and rigorous adherence to ICH guidelines and company SOPs, with remote work aligned

Qualifications

• Bachelor's degree in a scientific or healthcare field is required.
• 3–5 years of medical writing or regulatory writing experience, oncology preferred.
• Experience with CROs/biotech/pharma and regulatory submissions is preferred.
• Excellent written and verbal communication with attention to detail.

Responsibilities

• Prepare, develop, review, and edit oncology clinical and regulatory documents.
• Draft CSRs, protocols, amendments, and regulatory submissions.
• Collaborate with cross-functional teams to ensure accuracy and consistency.
• Ensure documents comply with ICH-GCP, FDA/EMA guidelines, and SOPs.
• Mentor junior writers and contractors as needed.
• Stay updated on oncology developments and regulatory changes.

Skills

Written and verbal communication

Attention to detail

Project management

Mentorship

Education

Bachelor's degree in a scientific or healthcare field

Advanced degree preferred

Tools

MS Office Suite

Document management systems

Regulatory writing templates

Job description

Hlx Life Sciences is seeking a Senior/Medical Writer with oncology clinical trials experience to join our expanding medical writing team. You will develop, review, and edit clinical and regulatory documents to support Phase I–III oncology programs and regulatory submissions.

The role requires strong scientific communication, the ability to translate complex data into clear content, mentorship of junior writers, and rigorous adherence to ICH guidelines and company SOPs, with remote work aligned